DCGI denies EUA to Covid vaccines shots of Bharat Biotech, Serum

Hyderabad: In a setback to two major pharma companies in the race for the vaccine for Coronavirus, the Drug Controller General of India (DCGI) has not granted the Emergency Use Authorization permission (EAU) to city-based Bharat Biotech and the Serum Institute of India (SII) for their respective vaccines, Covaxin and Covisheild.

The data submitted by both companies was found to be “insufficient” by the Central Drugs Standard Control Organisation (CDSCO) of the DCGI in terms of data on the trials of Indian patients, according to sources. The panel sought additional data on the safety and efficacy of their proposed shots.

Due to lack of data on Indian patients, the CDSCO subject expert committee, which met on Wednesday, found that the “data submitted of phase 1 and phase 2 trials was not sufficient”.

The DCGI said that Covid-19 vaccine candidates should have “at least 50 per cent efficacy in phase III clinical trials” for it to be widely deployed. The DCGI rules of 2019 state that there must be at least 3,000 patients on whom the vaccine has to be tested before approval.

Dr Kiran M, senior anaesthesiologist, Government Hospital, Nizamabad, said, “Phase III trials are still not complete. They are currently ongoing. Without data of these trials, the EUA cannot be given. There is no concept of EUA in India. This is for the first time vaccines are being taken up under this given the emergency of the pandemic. For this reason, scientists and drug controllers are very cautious.”

According to sources aware of the proceedings, “the data submitted by a company to CDSCO in order to get a EUA pertained to data of overseas patients by a company for phase III human clinical trials”.

In case of another company, recruitment of all 26,000 volunteers is still not complete, sources said. Given these lapses it will take time for the EUA to be given to these companies.

Experts argue that vaccine development takes time and evaluation of data requires time.

Dr Sanjay Reddy, senior pharmacist, said, “The data generation will be based on the dosage regime, time after doses and adverse effects, if any. These phases have to be completed. Till it is completed, it will not be known where this vaccine can be administered to people safely.”

Experts believe that the waiting period for EUA will take at least another month, if not ore. There are three committees which have to evaluate the request from these two companies, including the vaccine subject expert committee, the technical panel and the apex committee. The first committee, SEC, has asked for more data from the companies, which means that the wait for the vaccine from these two firms reaching people has gotten much longer.

The application by the Indian arm of US pharmaceutical firm Pfizer was not taken up for deliberation on Wednesday as the company sought more time for making a presentation before the committee, they said.

The recommendations by the SEC have been approved by the DCGI,” an official source was quoted by PTI to have said.

Bharat Biotech applied to DCGI for EUA on December 7 for Covaxin, developed indigenously by the firm in collaboration with the Indian Council of Medical Research, while Pune-based Serum Institute sought a nod for its Oxford vaccine, Covishield, on December 6.